NCT07447440

Brief Summary

The main objective of this project is to determine the possible association between the levels of certain bioactive lipids, which the body produces from dietary fatty acids, and tumor characteristics in breast cancer patients, as well as their relationship with overweight/obesity. Specific objectives are:

  • To analyse anthropometric and body composition changes.
  • To evaluate physical activity level.
  • To determine dietary profile.
  • To determine the adherence to Mediterranean dietary pattern.
  • To assess the quality of life.
  • To determine levels of specialized pro-resolving lipid mediators The target sample size is 60 subjects. Participants will be allocated in four groups:
  • Group 1: Postmenopausal healthy women with overweight/obesity (n=15)
  • Group 2: Postmenopausal healthy women with normoweight (n=15)
  • Group 3: Postmenopausal women with breast cancer and overweight/obesity (n=15)
  • Group 4: Postmenopausal women with breast cancer and normoweight (n=15)

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for all trials

Timeline
17mo left

Started Oct 2025

Typical duration for all trials

Geographic Reach
1 country

2 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress36%
Oct 2025Dec 2027

Study Start

First participant enrolled

October 15, 2025

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

February 25, 2026

Completed
6 days until next milestone

First Posted

Study publicly available on registry

March 3, 2026

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2027

Expected
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2027

Last Updated

March 11, 2026

Status Verified

March 1, 2026

Enrollment Period

2.1 years

First QC Date

February 25, 2026

Last Update Submit

March 9, 2026

Conditions

Breast CancerHealth, SubjectiveObesity

Keywords

BreastCancerPostmenopauseLipid mediatorsObesity

Outcome Measures

Primary Outcomes (1)

  • Lipid mediators profile

    Lipid mediators will be analysed by targeted lipidomic method.

    Clinical Investigation Day 1 and Clinical Investigation Day 3

Secondary Outcomes (39)

  • Body weight

    Clinical Investigation Day 1 and Clinical Investigation Day 3.

  • Height

    Clinical Investigation Day 1 and Clinical Investigation Day 3.

  • Body mass index

    Clinical Investigation Day 1 and Clinical Investigation Day 3.

  • Hip circumference

    Clinical Investigation Day 1 and Clinical Investigation Day 3.

  • Waist circumference

    Clinical Investigation Day 1 and Clinical Investigation Day 3.

  • +34 more secondary outcomes

Study Arms (4)

Group 1

Postmenopausal healthy women with overweight/obesity.

Other: Observational study (baseline)

Group 2

Postmenopausal healthy women with normoweight.

Other: Observational study (baseline)

Group 3

Postmenopausal women with breast cancer and overweight/obesity

Other: Observational study (baseline and 1 year)

Group 4

Postmenopausal women with breast cancer and normoweight.

Other: Observational study (baseline and 1 year)

Interventions

Observational study (baseline)OTHER

Data will be collected at a single time point.

Group 1Group 2
Observational study (baseline and 1 year)OTHER

Data will be collected at two time points during the study period.

Group 3Group 4

Eligibility Criteria

Sexfemale
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Postmenopuasal women.

You may qualify if:

  • Postmenopause (al least 1 year).
  • Normoweight or overweight/obesity.
  • No personal history of cancer.
  • Stable weight over the last 3 months (±5%).
  • Willing to sign the informed consent and comply with all study procedures.

You may not qualify if:

  • Personal history of cancer.
  • Current weight loss treatment (diet, supplementation, surgery, others...).
  • Bariatric surgery.
  • No stable pharmacological treatment for at least 3 months.
  • Diabetes treatment and hormone replacement therapy.
  • Relevant functional or structural abnormalities of the gastrointestinal tract, such as malformations, angiodysplasias, active peptic ulcers, chronic inflammatory or malabsorption diseases, hiatal hernia, chronic reflux, etc.
  • High alcohol intake, more than 14 units per week for women and 20 units per week for men.
  • Surgical interventions resulting in permanent sequelae of the gastrointestinal tract.
  • Liver disease, except for non-alcoholic fatty liver disease.
  • Cognitive and/or psychiatric impairment.
  • Poor compliance or difficulty following study procedures.
  • BREAST CANCER PARTICIPANTS:
  • Postmenopause (at least 1 year).
  • Normoweight or overweight/obesity.
  • Luminal subtype breast cancer, stages I-II, who require tumor resection and do not require preoperative treatment.
  • +3 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Center for Nutrition Research

Pamplona, Navarre, 31008, Spain

RECRUITING

Clínica Universidad de Navarra

Pamplona, Navarre, 31008, Spain

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Blood samples. Adipose tissue from breast cancer lumpectomies.

MeSH Terms

Conditions

Breast NeoplasmsObesityNeoplasms

Interventions

ObservationBaseLine dental cement

Condition Hierarchy (Ancestors)

Neoplasms by SiteBreast DiseasesSkin DiseasesSkin and Connective Tissue DiseasesOverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

MethodsInvestigative Techniques

Study Officials

  • Miguel Burgos, PhD

    Center for Nutrition Research

    PRINCIPAL INVESTIGATOR

  • María Jesús Moreno-Aliaga, PhD

    Center for Nutrition Research

    PRINCIPAL INVESTIGATOR

  • María Soledad García-Unciti, PhD

    Center for Nutrition Research

    STUDY CHAIR

  • Idoia Ibero-Baraibar, PhD

    Center for Nutrition Research

    STUDY CHAIR

  • Iosune Zubieta

    Center for Nutrition Research

    STUDY CHAIR

  • Salomé Pérez

    Center for Nutrition Research

    STUDY CHAIR

  • Asunción Redín

    Center for Nutrition Research

    STUDY CHAIR

  • Andrea Lara

    Center for Nutrition Research

    STUDY CHAIR

  • María Pilar Lostao, PhD

    Center for Nutrition Research

    STUDY CHAIR

  • Natalia Rodríguez-Spiteri, PhD

    Clínica Universidad de Navarra

    STUDY CHAIR

  • Begoña Olartecoechea, PhD

    Clínica Universidad de Navarra

    STUDY CHAIR

  • Ángel Vizcay, PhD

    Clínica Universidad de Navarra

    STUDY CHAIR

  • Marta Santisteban, PhD

    Clínica Universidad de Navarra

    STUDY CHAIR

Central Study Contacts

Miguel Burgos, PhD

CONTACT

+34948425600mburgosloz@unav.es

María Jesús Moreno-Aliaga, PhD

CONTACT

+34948425600mjmoreno@unav.es

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 25, 2026

First Posted

March 3, 2026

Study Start

October 15, 2025

Primary Completion (Estimated)

November 30, 2027

Study Completion (Estimated)

December 30, 2027

Last Updated

March 11, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will not share

Locations

ES(2)